New York City can claim an impressive, albeit eclectic, list of historical
firsts. In 1789, the metropolis served as the first capital of the
United States. Perhaps to ensure legislators didn't get too thirsty,
the city also was the first to open a public brewery. The first Yiddish
newspaper was published in the Big Apple, and the city hosted the
first meeting of the Boys Club of America.
But did you know that the ancestor of today's drug formulary was born
in the mid-19th century, based on the efforts of a consortium led
by New York City's Bellevue Hospital?
"The original idea was similar [to today's formularies], but
there weren't many medicines then," noted Joseph Deffenbaugh,
MPH, RPh, Director of Public Health and Quality for the American Society
of Health-System Pharmacists. "Apothecaries, who evolved to become
pharmacists, compounded from raw ingredients--mainly plant and animal
extracts and a few chemicals, including paregoric, belladonna and
digitalis. Opium-derived painkillers were the most useful treatments."
Historically, both apothecaries and physicians compounded medicines.
Sometimes doctors would even carry boxes of ingredients so that they
could compound on-site during house calls. As hospitals began sharing
formulas developed by individuals for making their own medicines,
concern arose about which drug materials to use for particular kinds
of patients. "Physicians and, later, pharmacists formed hospital
committees to assess therapeutic agents that were the most appropriate
to have available to treat that hospital's patients," Mr. Deffenbaugh
said. The committees, he added, "were the precursors to today's
Pharmacy & Therapeutics Committees or the Drug Use Policy Commission,
among other names."
Gradually, the original consortium (Bellevue Hospital and Columbia,
Cornell and New York University Colleges of Medicine) dissolved. Bellevue,
increasingly uneasy about the minimal controls on drug production,
safety and efficacy in the United States, then created a Formulary
Committee--believed to be the first--in the mid-1930s. Although other
institutions later established similar bodies, Bellevue's committee
is the longest continuously running group.
"It was one single committee, which was revolutionary at the
time," according to Robert S. Holzman, MD, Hospital Epidemiologist
at Bellevue Hospital and Chairman of its Committee on Drugs &
Formulary from 1982 to 2003. "Ours was a multidisciplinary group,
with pharmacists, chemists and pharmacologists. Over time, the physicians
took on a leading role."
Initially, the focus was on ensuring quality and efficacy of each
drug. Later, the committee began evaluating efficacy alone, as compared
to cost plus efficacy. One evolving role of Bellevue's formulary was
"to identify certain people who could safely use specific drugs,"
said Dr. Holzman, its co-chair from 1979 to 1982. "The committee
decided the hospital would restrict its formulary to drugs of known
composition and established efficacy, excluding medicines with secret
or proprietary mixtures. This spread across the country."
Committee members could designate certain drugs as unusually toxic
or requiring special knowledge in application. Anesthetic or muscle
paralytic agents were addressed early on, and their use could be restricted.
Only anesthesiologists, for example, could be certified to use an
anesthetic agent such as ether.
Bellevue's Formulary Committee has helped blaze several trails. Early
leaders in antibiotics control, they first took aim at gentamicin,
an aminoglycoside antibiotic used to treat a wide variety of bacterial
infections. After its introduction, the incidence of gram-negative
pathogens rose by 7% in one year. To avoid increasing resistance,
the committee instituted an unusual step--requiring that an infectious
disease specialist review each prescription, then call the pharmacy
to authorize it. With a specialist on call around the clock, the new
controls reduced gentamicin usage by approximately 50%, slowing the
development of resistance. The successful procedure was used for newer
antibiotics, to reduce the development of resistance to the drugs.
As both regulation and quality of medications improved, a wider range
of drugs with similar properties and toxicities offered Bellevue another
unexplored path--cost control. One new goal became using older drugs
as long as possible. "If a new drug has a really impressive advantage,
it's not always easy to delete the prior drug," observed Dr.
Holzman. Bellevue's committee quickly learned it could "ask for
the best prices from a vendor as a selection criterion, get a competitive
bid, use their drug for one year and keep seeking the best price."
By the mid-70s, the process included identifying therapeutically equivalent
drugs and choosing between them to buy the less expensive medication.
"We permitted the pharmacist to fill the prescription with whichever
drug was on hand, once they were declared therapeutically equivalent.
This was fairly unique at the time," Dr. Holzman said.
Lessons in Frugality
Bellevue, America's oldest public hospital, opened in 1736. Centuries
later, its status still demands significant restraints and innovations.
Steven DiCrescento, RPh, Director of Pharmacy at Bellevue from 1989
to 2002, recalls intensive training in extreme clinical and fiscal
responsibility. "That involved negotiating prices and market-share
agreements with manufacturers," he noted. "If a drug was
going to be presented to the formulary, you'd have done your homework
and gotten an idea of what their contract would look like, so you
could try to get a better price."
Rising expenses on a public hospital budget spurred creativity. "Bellevue
couldn't turn down patients needing state-of-the-art therapy,"
Mr. DiCrescento explained. "Looking for any way we could get
drugs paid for, we located and learned to tap into drug companies'
and federal programs that might cover patients who can't afford their
With resources always at a premium, Mr. DiCrescento had to think proactively,
to avert any potentially serious problem. "If you required 10
pharmacists and only had three, you still had to find ways to order,
and provide timely care." One of his effective approaches was
establishing interdisciplinary working groups. Cooperation between
two clinically expert disciplines--the Pharmacy and Nursing Departments--improved
patient care and safety.
Spreading the Knowledge
Currently Director of Pharmacy at NYU Medical Center, Mr. DiCrescento
said that Bellevue taught him to support patient safety while thinking
economically about managing rising costs, negotiating contracts, recognizing
parameters for a new formulary addition and understanding the pharmacoeconomic
business model. Today's goals at academic teaching institutions are
to provide a balance between patient safety and expense reduction
and revenue enhancement. He was able to bring to NYU his prior immersion
in cost control, and develop effective new therapeutic strategies
that reduced expenses and optimized patient safety.
"I brought that creative mentality and aggressive thinking,"
Mr. DiCrescento said. His familiarity with budgetary constraints at
Bellevue helped him accrue $1 million in potential savings and revenue
enhancements, in areas including high acquisition-cost drugs.
At NYU's pharmacy, he has expanded the responsibilities of the kind
of interdisciplinary working groups he had established at Bellevue.
Four groups (pediatrics, oncology, medicine and surgery) now explore
service improvements. "They've begun initiatives on timely delivery
of medications, therapeutic guidelines, drug doses, frequency of physician
orders and precautions doctors need to be aware of," said Mr.
DiCrescento, a member of all four groups.
Former Bellevue Director of Pharmacy Steven Alexander, RPh, MBA, became
Pharmacy Director at another New York City public hospital, Elmhurst
General, in 1991. "Most private hospitals didn't have large outpatient
pharmacies then, but the city hospitals did. At Bellevue, we were
early to computerize ours, and also expanded unit dose distribution."
Mr. Alexander brought both innovations to Elmhurst, where his previous
Bellevue discussions on allowing city hospitals to bill third parties
for outpatient medications soon came to fruition.
Bellevue was also one of the first New York hospitals to include a
clinical pharmacist on its total parenteral nutrition service--another
idea Mr. Alexander transported to Elmhurst. As multiple choices became
common within therapeutic classes, he had admired Bellevue for deciding
to select one representative drug, rather than all of those in a specific
class. By the late '80s, "you had drugs that might be on patent,
or unique entities; Bellevue could competitively bid within the class,
with its strong formulary committee. This was fairly unusual then,"
Mr. Alexander said. He recommended the approach to Elmhurst, where
he is now Associate Executive Director of Ancillary Services.
Like her predecessors, Bellevue's current Director of Pharmacy, Marcelle
Levy-Santoro, RPh/MS, continually seeks innovative solutions to a
public institution's special circumstances. "In spite of our
very tight formulary, Bellevue still spends about $900,000 a year
on nonformulary drugs to treat unusual conditions, as well as to fund
drugs for several hundred research studies here each year," Ms.
Levy-Santoro said. "This expense is somewhat offset by the Indigent
Drug Program recently implemented in this pharmacy, which generates
$2 million per year."
For each drug used in an investigative study, the P&T committee
discusses costs and alternatives, because they'll have to acquire
the medication for each nonsponsored clinical trial. "This adds
significantly to the expenses of the budget," she noted. "The
P&T committee must approve a study even before it goes to the
Research committee. Without approval from P&T, the trial can't
be approved by the hospital." Decisions about nonformulary drugs
are made jointly by the Director of Pharmacy and P&T.
The lessons Ms. Levy-Santoro and earlier pharmacy directors learned
from handling Bellevue's strict budget are relevant to any hospital
today. "Being required to keep expenses low at a city hospital
prepared me to guide the NYU staff towards certain cost savings initiatives,
and tie them to patient safety efforts," Mr. DiCrescento said.
"Instead of making them separate areas, we are trying to balance
costs with safety."
He added that his 13 years as Director of Pharmacy at Bellevue "taught
me that we shouldn't be afraid to take on new challenges in an ever-changing
environment--and to involve other people, because you can't do it